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Ef1

FDA UDI

Class II (US FDA UDI)

by Medshape, Inc.

Identity

Trade Name
EF1 FDA UDI
Generic Name
External orthopaedic fixation system noninvasive component, single-use FDA UDI
Device Name
Pin Guard 5-32in 3.96mm Blue FDA UDI
Model / Reference
14-1156-R0 FDA UDI
Description
Pin Guard 5-32in 3.96mm Blue FDA UDI

Identifiers

Primary DI / UDI-DI
00810028398009 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system noninvasive component, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: External orthopaedic fixation system noninvasive component, single-use

Ef1 by Medshape, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system noninvasive component, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medshape, Inc.

Sources (1)

  • FDA UDI d719537c-1a2b-47f5-b93d-0a2f4aba1d6b 33 fields · synced Jun 1, 2026